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Completed

NCT Number: NCT00902265

Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)

Documentation of the efficacy and safety of desmopressin (Nocturin®) 0.1 mg tablet. Observation of patients with benign prostate syndrome, in whom nocturia associated with nocturnal polyuria is treated with desmopressin (Nocturin®) 0.1 mg tablet focusing on number of nocturnal voids, ratio of night/24-h urine volume (%), duration of first undisturbed sleep period and quality of life.

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Key information

Conditions

Nocturia Associated With Nocturnal Polyuria

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Investigational Site - Pauwelsstraße 30, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Therapeutic need according to Summary of Product Characteristics
  • Written informed consent

Exclusion criteria

  • Contraindications according to Summary of Product Characteristics

Treatment and study plan

Desmopressin

Drug

desmopressin (Nocturin®) 0.1 mg tablet per day for 12 weeks

Other names: Nocturin®

Primary outcomes

  1. Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12

    Time frame: Baseline, Week 12

    The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure.

Secondary outcomes

  1. Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12

    Time frame: Baseline, Week 12

    The ratio of nighttime urine volume to 24-hour urine volume is calculated as the urine volume (volume of all voids after going to bed plus the first morning void) / 24-hour urine volume. Ratios are calculated at baseline and week 12 and difference between the two time points is reported here.

  2. Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12

    Time frame: Baseline, Week 12

    Initial period of undisturbed sleep is calculated as the number of hours between falling asleep and waking for the first time during the night to void. Change is calculated at Week 12 - baseline.

  3. Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12

    Time frame: Baseline, Week 12

    The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The first 7 items are summed into a total score and question urination frequency. They are scaled 0-5, with higher numbers indicating greater severity of symptoms. The last question (item 8) concerns QOL and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. The total scale across all questions is 0-41, with higher scores representing worse symptoms.

  4. Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12

    Time frame: Baseline, Week 12

    The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The last question (item 8) concerns Quality of Life (QOL) and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. Higher scores represent worse Quality of Life (QoL).

  5. Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12

    Time frame: Baseline, Week 12

    The LSEQ is a self-administered 10-item visual analog scale questionnaire designed to assess sleep quality. The 10 individual items are scored 1 to 100, with the total score ranging from 0 - 1,000. Higher numbers indicate lower sleep quality.

  6. Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)

    Time frame: Baseline, Week 12

    The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 1 and 2 participants were asked to estimate the frequency of both daytime voiding (all voids before going to bed excluding the first morning void) and rate the degree of bother of daytime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QoL).

  7. Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12

    Time frame: Baseline, Week 12

    The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 3 and 4, participants were asked to estimate the frequency of nighttime voiding (number of voids after going to bed plus the first morning void) and rate the degree of bother of nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QOL).

  8. Participants With Treatment Emergent Adverse Events (AEs)

    Time frame: Week 1 to Week 12

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

Efficacy and Safety of Nocturin 0.1 mg Tablets in Treatment of Nocturia in Patients With Nocturnal Polyuria, Lower Urinary Tract Symptoms (LUTS) and Benign Prostate Syndrome (BPS).

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 15, 2009
Registry last updated
Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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